Dear Editor,

In Tamar Kahn’s article “Tests on 'HIV Pill' to Stave Off Aids”, she says: “Half the volunteers will take a daily dose of Truvada, a pill that combines the antiretrovirals tenofovir and emtricitabine, and the rest will get a placebo. Neither the volunteers nor the researchers will know who gets which pill. All the participants will get intensive counselling and will be tested every month during the two-year study, and for six months afterwards.”

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals [See Warnings and Precautions (5.1)].

TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA or VIREAD, the components of TRUVADA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [See Warnings and Precautions (5.2)].

This study should clearly demonstrate whether or not an anti-HIV drug (Truvada in this case) does more good than harm.

Typically, those who conduct such a study report the difference between the placebo and drugged groups becoming HIV antibody positive. What is important is to also report the changes in the health between both groups.

I hope the organizers of this study will present the complete spectrum of results for all to judge.

David Rasnick, PhD

Member of the Presidential AIDS Advisory Panel